FMEA training for Healthcare - Sample


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A sample of slides used in our FMEA Training for Healthcare. This 3-day class is ideal for quality facilitators with hospitals and health systems. The key deliverable is a preliminary FMEA on a high-risk process of the client's choosing, complete with an improvement plan.

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FMEA training for Healthcare - Sample

  1. 1. Failure Mode & Effect Analysis (FMEA) Training for Healthcare © 2013 Workflow Diagnostics, Inc., unless otherwise noted. Any redistribution or commercial use of this presentation without permission from Workflow Diagnostics, Inc., is expressly forbidden.
  2. 2. • • • • Understand the purpose of the FMEA Understand the steps of the FMEA process Understand how to use FMEA Complete an exercise and actually create an FMEA to begin feeling comfortable with the process FMEA Training – Objectives Class objectives 2
  3. 3. • A team-based systematic and proactive approach for identifying the ways that a process can fail, why it might fail, the effects of that failure, and how it can be made safer. • The goal is to eliminate or minimize the potential for failures, to stop failures before harm reaches the patient, or to minimize the consequences of the failure. FMEA Training – FMEA Explained What is Failure Mode & Effect Analysis? 3 *Institute for Safe Medication Practices Canada (ISMP Canada)
  4. 4. • Aimed at preventing a tragedy, not simply responding to it • Doesn’t require previous bad experience or close call (“near-miss”) • Makes a system more fail-proof • Fault-tolerant FMEA Training – FMEA Explained Why Use FMEA? 4 *VA National Center for Patient Safety
  5. 5. • Practitioners in the systems know the specific vulnerabilities and failure points • Professional & moral obligation to “first do no harm” • Increased expectation that we create safe systems FMEA Training – FMEA Explained Why me? Why you? 5 *ISMP Canada
  6. 6. Historically….. • Accident prevention has not been a primary focus of hospital medicine • Misguided reliance on “faultless” performance by healthcare professionals • Hospital systems were not designed to prevent errors; they just reactively changed and were not typically proactive. FMEA Training – FMEA Explained Rationale for FMEA in Healthcare 6 *VA National Center for Patient Safety
  7. 7. Joint Commission Requirement (Standard LD.5.2 effective July 2001) • • • • • Select at least one high-risk process Identify potential “failure modes” For each “failure mode,” identify the possible effects For the most critical effects, conduct a root-cause analysis Redesign the process to minimize the risk of that failure mode or to protect patients from its effects • Test and implement the redesigned process • Identify and implement measures of effectiveness • Implement a strategy for maintaining the effectiveness of the redesigned process over time *VA National Center for Patient Safety FMEA Training – FMEA Explained • Identify and prioritize high-risk processes • Annually: 7
  8. 8. • Specimen identification • Hospital-acquired conditions – pressure ulcers, patient falls, VAP, surgical site infections, wrongsite surgery, etc. • Medication safety and dispensing • Fall prevention • Tests – delays and results • Infection control • Facility or new process design FMEA Training – FMEA Explained Healthcare Applications 8
  9. 9. How does FMEA work? • Severity • Occurrence • Detectability • Rate each failure mode as 1-10 for each of the three categories. (Some people use 1-5.) You do this to get to the ultimate goal: Reduce/eliminate risk to the patient FMEA Training – FMEA Explained • To narrow in on key failures to address, assign each failure mode three ratings: 9
  10. 10. Multiply the three ratings together to get the Risk Priority Number or RPN: • RPN = Severity  Occurrence  Detectability FMEA Training – FMEA Explained Risk Priority Number (RPN) 10
  11. 11. FMEA Process Steps 2 3 Select a High-Risk Clinical Process Assemble the team Map the Process 4 5 Brainstorm potential failure modes Identify effects of each failure mode 7 8 Implement and evaluate the redesign Develop mitigation strategies and redesign process (Severity; Occurrence; Detectability) 6 Prioritize the failure modes (RPN) 9 Monitor effectiveness of new processes. FMEA Training – Construction 1 11
  12. 12. • Select processes with high potential for having an adverse impact on the safety of individuals served. • Processes that: • • • • • • have variable input are complex non-standardized heavily dependent on human intervention performed under tight or loose time constraints tightly coupled and hierarchical (not team-oriented) are all candidates for consideration. *ISMP Canada FMEA Training – Construction Select a High-Risk Process 12
  13. 13. • Medication administration • Surgery • Transfusions • Restraints • Isolation • Emergency or resuscitative care • High-risk populations FMEA Training – Construction High-Risk Processes – Examples 13 *ISMP Canada
  14. 14. • • • • • Leader Facilitator Scribe/Recorder Process experts Include all areas involved in the process • “Outsider” – objective, “naïve” • 6-10 optimal size FMEA Training – Construction Assemble a team 14 *ISMP Canada
  15. 15. • Pick a manageable portion of the process • Make sure the topic is narrow enough of a focus (don’t try to cure world hunger) FMEA Training – Construction Map the Process 15 *ISMP Canada
  16. 16. Map the Process • Define beginning and end of the process • Chart the process as it is normally done, using the collective process knowledge of the team. • Number each step FMEA Training – Construction • If process is complex, identify the area to focus on. 16 *ISMP Canada
  17. 17. Brainstorm Potential Failure Modes Failure Mode #1 jProcess Step Failure Mode #2 Failure Mode #3 FMEA Training – Construction For each step in the process, list all the failure modes – all the ways the process could break down or go wrong Failure Mode #4 Could have multiple failures for each process step. 17
  18. 18. • Review each failure mode and identify the potential Effect(s) for each one • Try not to overlook any Effects -> results will impact the risk ratings done later FMEA Training – Construction Identify Effects If failure mode occurs, then what are the consequences? 18 *ISMP Canada
  19. 19. Severity Process Potential Potential step failure mode failure effects What is the impact on the What is In what ways customer if the can the step the failure step? go wrong? mode is not prevented or corrected? S E V Potential causes N What causes the step to go wrong? (i.e., How could the failure mode occur?) O C C Current process controls D E T R P N N What are the existing controls that either prevent the failure mode from occurring or detect it should it occur? N FMEA Training – Construction • The seriousness and Severity of the Effect (to the process or patient) of a failure if it should occur. N 19
  20. 20. • Need to have a scale to reference • Want to have a consistent scale throughout your organization • Make it meaningful to your organization • Start with 1 and end with 10 (don’t use zero) • 1 is best and 10 is worst • Relate 1 through 10 to each of Severity, Occurrence, and Detectability • Customize the scales to your organization FMEA Training – Construction Scoring Scale 20
  21. 21. • Also known as Frequency, it is the likelihood or number of times a specific failure (mode) could occur. • Before we assign ratings for the probability of occurrence , we’ll list the possible causes for each failure mode. • We’ll assign occurrence ratings to each cause of the failure. • 1 means it almost never happens-10 means it always happens Process Potential Potential failure step failure mode effects What is the impact on the In what ways What is customer if the can the step the step? failure mode is go wrong? not prevented or corrected? S E V N Potential causes What causes the step to go wrong? (i.e., How could the failure mode occur?) O C C Current process controls D E T R P N N What are the existing controls that either prevent the failure mode from occurring or detect it should it occur? N FMEA Training – Construction Occurrence N 21
  22. 22. In the Titanic example, we would rate the probability of an "iceberg that could potentially cause a hull failure” and not simply the “probability of a hull failure” FMEA Training – Construction Occurrence: 22
  23. 23. • The likelihood of detecting a failure or effect of a failure BEFORE it is felt by the patient. • Need to understand “Current Process Controls” • On a scale of 1-10, a “1” means the control is absolutely certain to detect the problem; “10” means the control has no chance to detect the problem or no control exists. Process Potential Potential failure step failure mode effects What is the impact on the In what ways What is customer if the can the step the step? failure mode is go wrong? not prevented or corrected? S E V N Potential causes What causes the step to go wrong? (i.e., How could the failure mode occur?) O C C Current process controls D E T R P N N What are the existing controls that either prevent the failure mode from occurring or detect it should it occur? N FMEA Training – Construction Detectability N 23
  24. 24. • “Detectability” means detecting the issue while we can still do something about it (before it reaches the customer/patient). • In the Titanic example, we’re not about detecting that the watertight compartments are flooded. We’re about detecting the iceberg and avoiding it. • That’s why we write “Process Controls,” “Current Controls” or “Current Process Controls” on our FMEA forms. FMEA Training – Construction Detectability 24
  25. 25. • Rates impact of failure on patient / system based on Severity, Occurrence and Detectability • Multiply three scores to obtain RPN  Severity – consequence of failure if it occurs  Occurrence – probability or actual frequency of failure  Detectability – probability of the failure being detected or prevented before the effect is realized FMEA Training – Construction Calculate Risk Priority Number (RPN) • Consider assigning priority to high Severity score even if RPN is low 25 *ISMP Canada
  26. 26. • Prioritize your efforts and improvement resources according to RPN. • High RPNs are more serious, should be addressed first, and deserve more effort and resources. • Note that functions with low RPN’s might often have “none” as the recommended action unless the action were particularly easy and low cost. FMEA Training – Construction Prioritizing RPN’s Note: May use a threshold for action (RPN or severity score) 26
  27. 27. Determine Root Cause(s) • • • • Fishbone (Ishikawa, Cause and Effect) 5-Why Pareto Scatter plots May be considered a separate step in FMEA Important: Determine true root cause of each potential Failure Mode before determining the mitigation strategies, if it is not readily apparent. FMEA Training – Construction Use appropriate root-cause analysis tools: 27
  28. 28. Reduce Severity • • • • • • • • • • Protection – gloves, masks, face shields Emergency shut-offs, fail-safe operation Sprinkler systems, fire doors Patient positioning Alternative materials, e.g., safety glass, Pyrex Warnings and messages Backup and redundant systems Patient and family awareness and education Expanding supplier base, multiple sources Shared design with vendors Also consider the impact on Occurrence and Detectability FMEA Training – Construction Examples to reduce Severity: 28
  29. 29. Prevent Occurrence • • • • • • • • • Continual improvement, problem-solving teams Increasing process performance (capability) Address multiple causes Move checks earlier in the process Staff education and training Error-proofing (poka-yoke) Better data collection, publish data Protective storage, inventory management Supplier evaluation and monitoring FMEA Training – Construction Examples to Prevent Occurrence 29
  30. 30. Improve Detectability • • • • • • • • • • In-process checks instead of post-process Automated checks and early warnings Barcodes, wristbands, asking name/DOB Better measuring devices, calibration checks Verification and double-checks Error-proofing (poka-yoke) Use colors, shapes to identify materials Statistical process control (SPC) Equipment and process validations Audits, system testing and monitoring FMEA Training – Construction Ways to improve Detectability (and Prevention) 30
  31. 31. • Important: Assign a person responsible for each action item, and a due date for completion • Follow-up on assigned actions • Verify actions taken have intended results FMEA Training – Construction Implement & Evaluate the New Process – Key Steps 31
  32. 32. Evaluate New Process • Determine what actions were taken – different than proposed? • Collect data on the new process • Calculate new RPNs based on actions taken • Reassess RPNs and determine next actions (on same item if RPN is still high, or new high RPN) • At regular intervals, re-assess to ensure the new process remains in place and effective FMEA Training – Construction After implementation: 32
  33. 33. FMEA TAKEAWAYS Healthcare FMEA –Takeaways SECTION 3 33
  34. 34. • Start small, aim for early success • Narrow … Narrow … Narrow • Use different team members from same dept. for different parts of the process (compare to RCA – not able to do that) Healthcare FMEA –Takeaways Tips for Success 34 *ISMP Canada
  35. 35. • • • • • • • • • • • Incomplete flowchart of the process Confusing Effects (symptoms) with Causes Not determining the true root causes Mixing Severity, Occurrence, Detectability Inconsistent scoring of Sev, Occ, Det Lack of RPN resolution (not a full 10-point scale) Not devoting enough time to the effort Not having a facilitator to keep process moving Not gathering input from all roles in the process Not having the right team members Low accountability for conducting Healthcare FMEA –Takeaways FMEA Pitfalls 35
  36. 36. • Safety-minded culture • Proactive problem resolution • Prevention of failures vs. rework and damage control • Failure-proof approach vs. punitive • Sense of control and ownership Healthcare FMEA –Takeaways Benefits of Implementing FMEA 36 *ISMP Canada